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Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria (REACT)

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RDTs & Provider Training on Malaria Diagnosis and Treatment
Extended provider training (Cameroon only)
School based malaria education (Nigeria only)
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Malaria focused on measuring cost effectiveness, provider knowledge, schools

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • the patient (or their caregiver) reports that the patient is suffering from a fever or has a history of fever in this illness episode
  • the patient is present at the health facility

Exclusion Criteria:

  • the patient is pregnant
  • the patient is <6 months old
  • the patient has signs or symptoms of severe malaria

Sites / Locations

  • Various health facilities
  • Various health facilities
  • Various health facilities

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Provider Intervention

Extended intervention

Arm Description

In Cameroon: Existing practice (with microscopy widely available) In Nigeria: Expected practice (RDTs will be provided with basic instructions)

Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment. This involved 1-day training on: 1) Malaria Diagnosis; 2) Rapid Diagnostic Testing; 3) Malaria Treatment. These modules explain that all febrile patients should be tested for malaria; procedures for using an RDT; that confirmed cases of uncomplicated malaria should be treated with an ACT; and test-negative patients should not be given an antimalarial. Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment. This involved a 2-day training workshop and support visits. The training covered the following topics: causes and symptoms of malaria; demonstration on how to use an RDT; updated malaria guidelines; and communications skills. The training used a combination of seminars and facilitated small-group work, such as a treatment algorithm game, problem-solving exercises, self-developed participatory drama and role-playing.

Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment AND enhanced provider training on improving quality of care. Clinicians received 3-days of training: the first day was identical to the basic intervention, while the remainder of the course covered three additional modules targeting improvements in quality of care: 4) Adapting to Change; 5) Professionalism; 6) Communicating Effectively. Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment AND School-based malaria education intervention (with drama, peer-health education and distribution of health education materials). In addition, teachers and Peer Health Educators were offered support to hold malaria events in which parents, guardians, and other community members could participate in the same types of activities.

Outcomes

Primary Outcome Measures

Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria
Recommended treatment is defined as Febrile patients should be tested for malaria, either using microscopy or using a RDT Artemisinin-based Combination Therapy (ACT) should be provided if the patient has a positive malaria test result No antimalarial should be provided if patient has a negative test result.

Secondary Outcome Measures

Health worker knowledge
Mean score (and standard deviation) in HW knowledge on malaria diagnosis and treatment

Full Information

First Posted
May 9, 2011
Last Updated
September 8, 2016
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Yaounde, University of Nigeria, Enugu Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01350752
Brief Title
Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria
Acronym
REACT
Official Title
A Cost-effectiveness Analysis of Alternative Strategies for the Deployment of ACTs at the Community Level in Cameroon and Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Yaounde, University of Nigeria, Enugu Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the REACT project is to evaluate the effectiveness and cost-effectiveness implications of interventions designed to improve health worker practice in providing treatment for uncomplicated malaria to febrile patients attending health facilities in Cameroon and Nigeria.
Detailed Description
NIGERIA Two interventions will be evaluated: (i) provider intervention including introducing RDTs with detailed instructions, one-off training, job aides and on-the-site supportive supervisory visits and (ii) combined provider intervention [as under (i)]and community-based intervention (using primary and secondary schools as focal points)including school malaria events with drama, peer-health education, distribution of health education materials. Types of facilities include: public primary health facilities, private pharmacies and private Patent Medicine Dealers (PMDs)in Enugu State. The two sites in Enugu State are: Enugu urban (comprising of Enugu East, Enugu South and Enugu North Local government areas (LGA) and Udi LGA. The impact of the interventions will be evaluated using a 3-arm stratified, cluster randomized trial with a cluster defined as a geographical community and the two study sites as the strata. The three arms of the trial are: Intervention - Provider intervention Intervention - Provider plus school-based malaria activities Control - Expected practice (once RDTs have been introduced) CAMEROON Two interventions will be evaluated: (i) the introduction of rapid diagnostic tests (RDTs) with basic provider training on malaria diagnosis and treatment; and (ii) the basic provider training [as under (i)] plus enhanced provider training to improve the quality of care that includes aspects of interactive self awareness, communication modules between health workers and also between health workers and patients. Types of facilities include: public district hospitals, public health centres (including integrated health centres), mission hospitals and mission health centres (including integrated health centres)in Yaoundé and Bamenda Health Districts. A stratified, cluster randomized trial will be used in which health facilities are the cluster and the two study sites are the strata. The three arms of the trial are: Intervention - RDTs with basic provider training; Intervention - RDTs with basic plus enhanced provider training; Control - which represents current practice and neither intervention will be implemented.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
cost effectiveness, provider knowledge, schools

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6513 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
In Cameroon: Existing practice (with microscopy widely available) In Nigeria: Expected practice (RDTs will be provided with basic instructions)
Arm Title
Provider Intervention
Arm Type
Active Comparator
Arm Description
Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment. This involved 1-day training on: 1) Malaria Diagnosis; 2) Rapid Diagnostic Testing; 3) Malaria Treatment. These modules explain that all febrile patients should be tested for malaria; procedures for using an RDT; that confirmed cases of uncomplicated malaria should be treated with an ACT; and test-negative patients should not be given an antimalarial. Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment. This involved a 2-day training workshop and support visits. The training covered the following topics: causes and symptoms of malaria; demonstration on how to use an RDT; updated malaria guidelines; and communications skills. The training used a combination of seminars and facilitated small-group work, such as a treatment algorithm game, problem-solving exercises, self-developed participatory drama and role-playing.
Arm Title
Extended intervention
Arm Type
Active Comparator
Arm Description
Cameroon: Introduce malaria RDTs with basic provider training and job aids on malaria diagnosis and treatment AND enhanced provider training on improving quality of care. Clinicians received 3-days of training: the first day was identical to the basic intervention, while the remainder of the course covered three additional modules targeting improvements in quality of care: 4) Adapting to Change; 5) Professionalism; 6) Communicating Effectively. Nigeria: Introduce malaria RDTs with provider training and job aids on malaria diagnosis and treatment AND School-based malaria education intervention (with drama, peer-health education and distribution of health education materials). In addition, teachers and Peer Health Educators were offered support to hold malaria events in which parents, guardians, and other community members could participate in the same types of activities.
Intervention Type
Behavioral
Intervention Name(s)
RDTs & Provider Training on Malaria Diagnosis and Treatment
Other Intervention Name(s)
RDTs supplied: SD Bioline, Training course
Intervention Description
In Cameroon and Nigeria, malaria RDTs will be made available in health facilities and health care providers will receive training and job aids on malaria diagnosis and treatment. The training course covers the following topics: clinical and parasitological diagnosis of malaria, how to use a rapid diagnostic test, algorithm based on malaria test result, recommended treatment for confirmed malaria cases (including dosage and regimen for artemisinin-based combination therapies), advice for treatment of test-negative patients
Intervention Type
Behavioral
Intervention Name(s)
Extended provider training (Cameroon only)
Other Intervention Name(s)
provider training, quality of care
Intervention Description
2-day training course which supplements basic provider training on malaria diagnosis and treatment, which focuses on understanding change in malaria treatment guidelines, professionalism, and communication skills
Intervention Type
Behavioral
Intervention Name(s)
School based malaria education (Nigeria only)
Other Intervention Name(s)
school based intervention, teachers, peer health educators
Intervention Description
Schools will be invited to undertake activities to raise awareness about malaria RDTs and treatment among children and community members. The intervention includes training teachers on peer health education, malaria awareness activities and providing support to hold a malaria educational event
Primary Outcome Measure Information:
Title
Proportion of febrile patients receiving treatment as recommended in clinical guidelines for uncomplicated malaria
Description
Recommended treatment is defined as Febrile patients should be tested for malaria, either using microscopy or using a RDT Artemisinin-based Combination Therapy (ACT) should be provided if the patient has a positive malaria test result No antimalarial should be provided if patient has a negative test result.
Time Frame
As patients exit the health facility
Secondary Outcome Measure Information:
Title
Health worker knowledge
Description
Mean score (and standard deviation) in HW knowledge on malaria diagnosis and treatment
Time Frame
Two time points: (i) pre and post training evaluation and (ii) during the provider survey (3 months after implementation of interventions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: the patient (or their caregiver) reports that the patient is suffering from a fever or has a history of fever in this illness episode the patient is present at the health facility Exclusion Criteria: the patient is pregnant the patient is <6 months old the patient has signs or symptoms of severe malaria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Wiseman
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wilfred Mbacham
Organizational Affiliation
University of Yaounde I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Obinna Onwujekwe
Organizational Affiliation
University of Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Various health facilities
City
Yaounde
State/Province
Central Region
Country
Cameroon
Facility Name
Various health facilities
City
Bamenda
State/Province
North West Region
Country
Cameroon
Facility Name
Various health facilities
City
Enugu
State/Province
Enugu State
Country
Nigeria

12. IPD Sharing Statement

Citations:
PubMed Identifier
26309023
Citation
Onwujekwe O, Mangham-Jefferies L, Cundill B, Alexander N, Langham J, Ibe O, Uzochukwu B, Wiseman V. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial. PLoS One. 2015 Aug 26;10(8):e0133832. doi: 10.1371/journal.pone.0133832. eCollection 2015.
Results Reference
derived
PubMed Identifier
25103303
Citation
Mbacham WF, Mangham-Jefferies L, Cundill B, Achonduh OA, Chandler CI, Ambebila JN, Nkwescheu A, Forsah-Achu D, Ndiforchu V, Tchekountouo O, Akindeh-Nji M, Ongolo-Zogo P, Wiseman V. Basic or enhanced clinician training to improve adherence to malaria treatment guidelines: a cluster-randomised trial in two areas of Cameroon. Lancet Glob Health. 2014 Jun;2(6):e346-58. doi: 10.1016/S2214-109X(14)70201-3. Epub 2014 Apr 25.
Results Reference
derived
PubMed Identifier
24885621
Citation
Achonduh OA, Mbacham WF, Mangham-Jefferies L, Cundill B, Chandler C, Pamen-Ngako J, Lele AK, Ndong IC, Ndive SN, Ambebila JN, Orang-Ojong BB, Metoh TN, Akindeh-Nji M, Wiseman V. Designing and implementing interventions to change clinicians' practice in the management of uncomplicated malaria: lessons from Cameroon. Malar J. 2014 May 29;13:204. doi: 10.1186/1475-2875-13-204.
Results Reference
derived
PubMed Identifier
22682276
Citation
Wiseman V, Ogochukwu E, Emmanuel N, Lindsay J M, Bonnie C, Jane E, Eloka U, Benjamin U, Obinna O. A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria: study protocol for a randomized controlled trial. Trials. 2012 Jun 9;13:81. doi: 10.1186/1745-6215-13-81.
Results Reference
derived
Links:
URL
http://www.actconsortium.org/
Description
ACT Consortium

Learn more about this trial

Research on the Economics of Artemisinin Combination Therapy (ACTs) for the Treatment of Malaria

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